Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT07247851
Status:
COMPLETED
Last Update Posted:
2025-11-25
First Post:
2025-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Title of the Protocol: Combined Use of Vaginal Clindamycin Cream and Oral Metronidazole Versus Oral Metronidazole
Sponsor:
Ain Shams Maternity Hospital
Organization:
Study Overview
Official Title:
Title of the Protocol: Combined Use of Vaginal Clindamycin Cream and Oral Metronidazole Versus Oral Metronidazole in Treatment of Bacterial Vagionosis: A Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Bacterial vaginosis (BV) constitutes a gynecological condition characterized by an alteration of the vaginal microenvironment and more specifically an alteration of the normal Lactobacillus-dominated vaginal flora, to a flora that includes a variety of facultative and obligatory anaerobic bacteria; this alteration causes offensive smelling vaginal discharge, leading to significant psychological distress and a reduction in quality of life and may be associated with adverse outcomes following a gynecological/obstetrical surgical intervention, such as an increased risk of post-operative infections after pelvic surgery.
It has been observed in 29% of reproductive-age individuals in the United States, and the prevalence of BV varies with race and ethnicity
It has been observed in 29% of reproductive-age individuals in the United States, and the prevalence of BV varies with race and ethnicity
Detailed Description:
Bacterial vaginosis (BV) constitutes a gynecological condition characterized by an alteration of the vaginal microenvironment and more specifically an alteration of the normal Lactobacillus-dominated vaginal flora, to a flora that includes a variety of facultative and obligatory anaerobic bacteria
symptoms in cases of symptomatic BV include an elevated vaginal pH, grey-white milky vaginal discharge, itching, and a "fishy" odor. moreover, It is well known that unfavorable outcomes of early pregnancy including premature rupture of membranes (PROM), chorioamnionitis, preterm delivery, spontaneous abortion, and low birth weight can be exacerbated by BV during pregnancy.
Aside from the evaluation of clinical symptoms, the gold standard for the confirmation of BV diagnosis is the Nugent score based on Gram staining and observing the number of lactobacilli and other morphotypes (different shapes of gardenerellavaginalis, prevotella species, and mobiluncus) which are scored between 0 and 10, where scores 7-10 show BV. However, traditional assessment using Nugent scoring typically requires more time, resources, and expertise, which can impact its use in a clinical setting. The preferred alternative in practice is the Amsel scoring or a Gram stain.
The Amsel scoring system is simple to use and is based on four predefined criteria: (I) the presence of homogeneous, thin, greyish white vaginal discharge, (II) a vaginal pH over 4.5, (III) a positive whiff-amine test, and (IV) \>20% clue cells/high power field on a wet mount of vaginal secretions. Yet, important diagnostic tools for BV are the phase contrast microscope and a trained user.
Oral divided dose metronidazole is the most widely used therapy and serves as the standard of care for bacterial vaginosis. Despite its favorable pharmacodynamics, recurrence rates of BV are high, 69-80% within 12 months. The causes of recurrence are still not known, whether from development of a treatment resistant bacterial biofilm on the vaginal mucosa, reinfection from a sexual partner, or host factors leading to failure to re-establish the normal vaginal flora.Two-thirds of cases complain from bacterial vaginosis recurrence within a year of treatment.
Metronidazole treatment is also associated with side effects which can limit acceptability and adherence. Patients also dislike taking multiple courses of antibiotics and are concerned that they may acquire resistant bacteria. Preventing and reducing antimicrobial resistance is also a public health priority through improving antibiotic stewardship including a reduction in antibiotic use. The limited efficacy of current treatment for bacterial vaginosis and a need to reduce antibiotic exposure highlight the need for alternative therapies.
Clindamycin phosphate was approved by the united states (U.S) Food and Drug Administration (FDA) in 2021 for the treatment of bacterial vaginosis. It is unique among bacterial vaginosis treatments in that it is a thermosetting bioadhesive intravaginal cream formulated with 2% clindamycin phosphate designed to release the active ingredient for an extended period of time. Reduced leakage should result in better user compliance, and, because clindamycin is more effective with increased exposure time, the increased retention time is supposed to result in higher cure rates
symptoms in cases of symptomatic BV include an elevated vaginal pH, grey-white milky vaginal discharge, itching, and a "fishy" odor. moreover, It is well known that unfavorable outcomes of early pregnancy including premature rupture of membranes (PROM), chorioamnionitis, preterm delivery, spontaneous abortion, and low birth weight can be exacerbated by BV during pregnancy.
Aside from the evaluation of clinical symptoms, the gold standard for the confirmation of BV diagnosis is the Nugent score based on Gram staining and observing the number of lactobacilli and other morphotypes (different shapes of gardenerellavaginalis, prevotella species, and mobiluncus) which are scored between 0 and 10, where scores 7-10 show BV. However, traditional assessment using Nugent scoring typically requires more time, resources, and expertise, which can impact its use in a clinical setting. The preferred alternative in practice is the Amsel scoring or a Gram stain.
The Amsel scoring system is simple to use and is based on four predefined criteria: (I) the presence of homogeneous, thin, greyish white vaginal discharge, (II) a vaginal pH over 4.5, (III) a positive whiff-amine test, and (IV) \>20% clue cells/high power field on a wet mount of vaginal secretions. Yet, important diagnostic tools for BV are the phase contrast microscope and a trained user.
Oral divided dose metronidazole is the most widely used therapy and serves as the standard of care for bacterial vaginosis. Despite its favorable pharmacodynamics, recurrence rates of BV are high, 69-80% within 12 months. The causes of recurrence are still not known, whether from development of a treatment resistant bacterial biofilm on the vaginal mucosa, reinfection from a sexual partner, or host factors leading to failure to re-establish the normal vaginal flora.Two-thirds of cases complain from bacterial vaginosis recurrence within a year of treatment.
Metronidazole treatment is also associated with side effects which can limit acceptability and adherence. Patients also dislike taking multiple courses of antibiotics and are concerned that they may acquire resistant bacteria. Preventing and reducing antimicrobial resistance is also a public health priority through improving antibiotic stewardship including a reduction in antibiotic use. The limited efficacy of current treatment for bacterial vaginosis and a need to reduce antibiotic exposure highlight the need for alternative therapies.
Clindamycin phosphate was approved by the united states (U.S) Food and Drug Administration (FDA) in 2021 for the treatment of bacterial vaginosis. It is unique among bacterial vaginosis treatments in that it is a thermosetting bioadhesive intravaginal cream formulated with 2% clindamycin phosphate designed to release the active ingredient for an extended period of time. Reduced leakage should result in better user compliance, and, because clindamycin is more effective with increased exposure time, the increased retention time is supposed to result in higher cure rates
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: